New Indication for Gammagard

The U.S. Food and Drug Administration (FDA) approved an additional indication for Gammagard Liquid^® [immune globulin infusion (human) 10% solution – Takeda] on Jan. 26, 2024. It now can be used to alleviate neuromuscular disability and impairment for adults who have chronic inflammatory demyelinating polyneuropathy (CIDP). Believed to affect as many as 40,000 patients in the U.S., CIDP is difficult to diagnose because its symptoms are vague and inconsistent. Caused by inflammation of the nerves, it results in pain, tingling, and weakness — especially in the arms and legs. The usual treatment is intravenous doses of immunoglobulin (IVIG). Although Gammagard Liquid may be injected subcutaneously (SC), doses for CIDP must be infused IV. Treatment starts with one dose at 2gm/kg divided and given over two to five successive days. Then, maintenance dosing is 1gm/kg infused over one to four straight days once every three weeks. Gammagard Liquid has previous indications for patients at least two years old as replacement therapy for primary immunodeficiency (PI) and for adults as a maintenance treatment to boost muscle strength and decrease disability resulting from multifocal motor neuropathy (MMN). A boxed warning cautions that using any immune globulin may be associated with kidney problems and blood clots, so kidney function and blood viscosity should be checked frequently. Complete revised prescribing information is here.

Avycaz Gets Extended Pediatric Indication

The indications for AbbVie’s antibacterial/beta-lactamase inhibitor, Avycaz^® (ceftazidime/avibactam) injection were expanded by the FDA on Jan. 26, 2024, to include newborns whose gestational age is at least 31 weeks. Previously, its use was limited to children who were three months of age or older. As monotherapy, it treats complicated (associated with an underlying condition) urinary tract infections and bacterial pneumonia that are acquired in a healthcare facility or related to the use of a ventilator. Along with another antibiotic, metronidazole, it is used for complicated infections within the abdomen. Typically, patients who need it have few or no other options for treatment after other drugs have failed. For patients under the age of 18 years old, dosing is based on the patient’s body weight. It is given as a two-hour-long IV infusion once every eight hours for five days to 14 days depending on the condition being treated. Here is the updated prescribing information.

Aduhelm Being Discontinued

Biogen has decided to stop manufacturing (aducanumab-avwa) injection and to terminate the clinical trial being conducted for its full approval. The amyloid beta-directed antibody was awarded the FDA’s Accelerated Approval in June 2021 for treating mild Alzheimer’s disease. Given IV once every four weeks, it was the first drug that targets underlying protein deposits to treat the cause of the disease. The decision to discontinue it is based on business reasons, not on effectiveness issues or safety concerns with Aduhelm. Biogen will be concentrating financial resources on its other Alzheimer’s drug, Leqembi^® (lecanemab-irmb) injection, and on investigational drugs still in clinical trials for the disease. Developed jointly with Eisai, Leqembi was fully approved by the FDA to treat mild Alzheimer’s disease on July 6, 2023. Like Aduhelm, it is an antibody against amyloid beta that is administered by IV infusions — but it is dosed once every two weeks. Leqembi’s full prescribing information is here.

MedWatch Update

Unapproved Eye Drops

The FDA alerted consumers on Jan. 31, 2024, about using some over-the-counter (OTC) eye drops that primarily are sold online. With the brand names FivFivGo, Rebright, and South Moon, they do not include any active ingredients, and some make false claims that they can treat serious eye conditions, such as glaucoma. Samples from at least one of them are contaminated with bacteria that could cause severe eye infections. They may cause eye irritation and pain, as well. None of the three has been approved for sale in the United States. Packaging for the questionable eye drops closely resembles packaging for Lumify® (brimonidine ophthalmic solution, 0.025%), which is used to alleviate eye redness. Lumify is safe to use. The FDA recommends that anyone who has FivFivGo, Rebright or South Moon eye drops should dispose of them. Any side effects that may be related to using one of them should be reported to a doctor or the FDA at MedWatch. More information, including photos of the products’ boxes and bottles, is in the FDA’s notice.

Recall On Jan. 25, 2024, Azurity Pharmaceuticals announced the recall of one lot of the stimulant medication Zenzedi^® (dextroamphetamine sulfate tablets) 30mg to the consumer level after one bottle was found to contain the antihistamine carbinoxamine maleate. Zenzedi is approved for treating attention deficit hyperactivity disorder (ADHD) and narcolepsy. Patients who take carbinoxamine instead of Zenzedi could experience undertreatment of their disease symptoms. In addition, adverse effects from taking the antihistamine carbinoxamine maleate can include drowsiness and central nervous system depression. The FDA notice is here.